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RAFI Press Release, May 8 1997
On WWW see http://www.rafi.ca for more information.

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       Dolly Goes to Market
World Patents on Sheep Clones Include Humans
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While the entire world was caught up in the scientific excitement and
ethical conundrums created by the cloning of sheep late last February, few
noticed that Dolly's inventors had applied for patents covering the cloning
technology. As the world debated the brave new world of medical advances
and risks implicated in the cloning achievement, a few watched to see if
the patents - if granted - would encompass all mammals - or deliberately
exclude human beings. "The worldwide patents are now out - and we're in,"
Edward Hammond of RAFI observes. "This isn't just a mutton monopoly, the
patents cover everything that crawls, flies, swims, walks or talks," he
adds. "The issue is never just the science," RAFI's Jean Christie
continues, "its who owns and controls the technology."

Patents Out - People In: The twin patents were granted under a convention
of the World Intellectual Property Organization (WIPO) - a United Nations
agency headquartered in Geneva. Patents No. WO 97/07668 and WO 97/07669
were published on March 6, just a few days after the world learned of the
cloning success. RAFI has since been working to determine the legal scope
of the patent claims and the degree to which the world's major patenting
jurisdictions have agreed to the patents. "The applications covered
virtually every country that has a patent system." Hammond says, "Most
patent offices would have accepted Dolly without even knowing the
implications."

To confirm that the patents include human beings, RAFI contacted both the
Scotland-based Roslin Institute, and PPL Therapeutics, the company
established by Roslin to commercialize its research. Although Dolly's
"inventors" are adamant that they have no commercial interest in - and no
moral tolerance of - human cloning, Roslin Institute confirms that the
patents cover all animals, including humans. While some other biotech
companies, confronted with similar ethical concerns, have worded their
patents to specifically exclude humans, the Roslin patents deliberately
make no such exclusion. Asked why, the Institute told RAFI that the
inclusion of humans would ensure that nobody else could lay claim to human
cloning and thus Roslin would try to ensure that humans would not be cloned.

Pulling the Wool over ...? RAFI does not question the sincerity of the
Institute's intentions. However, RAFI's Hope Shand points out, "The ethics
and fate of human cloning is not a matter to be entrusted to the Roslin
Institute. This is an issue of profound global importance and must be
resolved at the highest levels."

The Roslin Institute has agreed to give an exclusive license to PPL
Therapeutics for the production of therapeutic proteins in the milk of
genetically modified animals. PPL is a small biotech company with offices
in the UK and the USA. According to PPL Managing Director, Ron James,
"We're still talking to them [Roslin] about other licensing uses and I
expect that others are talking to them as well." Depending on the
conditions of licensing agreements, PPL or other companies could be well
within their rights to develop human cloning and/or to sub-license other
companies to pursue this research opportunity. PPL has research agreements
with three major pharmaceutical enterprises with interests in human
therapeutics. "Behind the Roslin Institute is PPL," Shand reports, "but
behind PPL are Boehringer Ingelheim of Germany, Novo Nordisk of Denmark,
and American Home Products of the US. These are very large players in the
life industry. In particular, Boehringer Ingelheim is actively
collaborating with human genomic companies.

Edward Hammond of RAFI notes that the patent gives exclusive monopoly over the
cloning of all animals - not excluding humans - until at least 2017. "Some
of the inventors could expire before the patent does," Hammond warns.

No "Silence of the Lambs": RAFI will fight the Dolly patents. This weekend,
Edward Hammond will fly to Geneva to attend the Assembly of the World
Health Organization (WHO). The UN body has already resolved to oppose human
cloning but Hammond hopes to encourage government delegations to also call
for the revocation of the two patents in each country. RAFI is also
pressing for the WHO to tighten its guidelines covering the ethics of
medical research. While in Geneva, Edward Hammond will also visit WIPO and
the World Trade Organization to investigate means by which the patents
could be disallowed under a rarely-used "ordre public" ("public morality")
clause in the World Trade Agreement.

Meanwhile, RAFI's Executive Director, Pat Mooney, will fly to Rome to meet
with officials of the UN Food and Agriculture Organization (FAO) to discuss
the impact of livestock cloning on animal diversity. "The patent
implications are not just for people but for animal genetic resources as
well," Mooney states. "The immediate impact may be felt on the farm and
steps must be taken to ensure that cloning does not destroy breed
diversity. We are losing livestock breed diversity at the rate of 5% per
year." he adds, "Cloning could make the situation much worse. We need to
retain our genetic options in order to confront both new diseases and new
opportunities."

Dolly Goes to Court: Finally, RAFI will take the Dolly patents issue -
along with a number of other specific patent concerns - to a Special
Session of the UN General Assembly from June 23-27 in New York. "The Dolly
patents are only the most recent of a number of instances where patent
monopolies threaten public morality," Jean Christie asserts. "We are hoping
that the General Assembly will agree to ask the World Court (the
International Court of Justice at The Hague) for an advisory opinion. The
Court's views could significantly affect the work of WIPO and the World
Trade Organization."

For more information see: http://www.rafi.ca or contact www@rafiusa.org or
rafican@rafi.ca

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